Trial Outcomes & Findings for Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia (NCT NCT03551210)

NCT ID: NCT03551210

Last Updated: 2023-02-16

Results Overview

Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy; chest roentgenograms (CT scans) are cured or improved

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 342 participants
• Primary outcome timeframe: Visit 4 (within 7-9 days after last dose)
• Results posted on: 2023-02-16

Participant Flow

The recruitment of subjects was conducted by 25 clinical sites in Russia between May 2016 and 2017. Totally 356 patients were screened and 342 eligible patients were randomized to receive Nemonoxacin or Tavanic in 1:1 ratio (171 subjects in each group).

Participant milestones

Measure	Nemonoxacin Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Overall Study STARTED	171	171
Overall Study COMPLETED	161	151
Overall Study NOT COMPLETED	10	20

Reasons for withdrawal

Measure	Nemonoxacin Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Overall Study Adverse Event	5	6
Overall Study Withdrawal by Subject	1	7
Overall Study Needed in other antibiotic treatment	2	5
Overall Study Lost to Follow-up	1	1
Overall Study Absence of visit 4 and 5	1	0
Overall Study No drug for dispensing	0	1

Baseline Characteristics

Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia

Baseline characteristics by cohort

Measure	Nemonoxacin n=169 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=166 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion	Total n=335 Participants Total of all reporting groups
Age, Continuous	42.0 years n=5 Participants	43.3 years n=7 Participants	42.6 years n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	100 Participants n=7 Participants	203 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized European	168 Participants n=5 Participants	166 Participants n=7 Participants	334 Participants n=5 Participants
Body Mass Index (BMI)	25.4 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants	26.1 kg/m^2 STANDARD_DEVIATION 5.6 • n=7 Participants	25.8 kg/m^2 STANDARD_DEVIATION 5.5 • n=5 Participants

PRIMARY outcome

Timeframe: Visit 4 (within 7-9 days after last dose)

Population: Modified Intent-To-Treat population (mITT) - all randomized patients received at least one dose of investigational drugs, in compliance with at lest minimal disease criteria (inclusion criteria 3 and 4) and had at least one assessment of clinical efficacy in this study

Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy; chest roentgenograms (CT scans) are cured or improved

Outcome measures

Measure	Nemonoxacin n=169 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=166 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Number of Patients With Clinical Success as Judged by the Investigator Clinical success	158 Participants	145 Participants
Number of Patients With Clinical Success as Judged by the Investigator Clinical non-efficacy	6 Participants	8 Participants
Number of Patients With Clinical Success as Judged by the Investigator Indefinite response	5 Participants	13 Participants

SECONDARY outcome

Timeframe: Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)

Population: Modified Intent-To-Treat population (mITT) - all randomized patients received at least one dose of investigational drugs, in compliance with at lest minimal disease criteria (inclusion criteria 3 and 4) and had at least one assessment of clinical efficacy in this study

Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy

Outcome measures

Measure	Nemonoxacin n=169 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=166 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Number of Patients With Clinical Success as Judged by the Investigator Visit 2 · Indefinite response	1 Participants	7 Participants
Number of Patients With Clinical Success as Judged by the Investigator Visit 2 · Clinical success	164 Participants	154 Participants
Number of Patients With Clinical Success as Judged by the Investigator Visit 2 · Clinical non-efficacy	4 Participants	5 Participants
Number of Patients With Clinical Success as Judged by the Investigator Visit 3 · Clinical success	160 Participants	151 Participants
Number of Patients With Clinical Success as Judged by the Investigator Visit 3 · Clinical non-efficacy	6 Participants	7 Participants
Number of Patients With Clinical Success as Judged by the Investigator Visit 3 · Indefinite response	3 Participants	8 Participants

SECONDARY outcome

Timeframe: Visit 5 (within 21-23 days after last dose)

Population: All patients of mITT population achieved clinical success on Visit 4

Outcome measures

Measure	Nemonoxacin n=158 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=145 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Number of Patients With Infection Relapse	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Visit 2 (day 4/8 ot treatment)

Population: Modified Intent-To-Treat population (mITT) - all randomized patients received at least one dose of investigational drugs, in compliance with at lest minimal disease criteria (inclusion criteria 3 and 4) and had at least one assessment of clinical efficacy in this study

Outcome measures

Measure	Nemonoxacin n=169 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=166 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Time to Switch Therapy From Intravenous to Oral Therapy	4 days Interval 3.0 to 5.0	4 days Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Up to 21-23 days after last dose

Population: Modified Intent-To-Treat population (mITT) - all randomized patients received at least one dose of investigational drugs, in compliance with at lest minimal disease criteria (inclusion criteria 3 and 4) and had at least one assessment of clinical efficacy in this study

Outcome measures

Measure	Nemonoxacin n=169 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=166 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Number of Patients Required for Other Antibiotic Treatment	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)

Population: b-mITT - Patients in the mITT population whose bacterial culture had at least one baseline bacterial isolate

Microbiological response is evaluated as microbiological success if culture study demonstrates eradication of pathogen or no material available for culture because of clinical success

Outcome measures

Measure	Nemonoxacin n=20 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=16 Participants Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Number of Patients With Microbiological Success Visit 2	17 Participants	16 Participants
Number of Patients With Microbiological Success Visit 3	19 Participants	16 Participants
Number of Patients With Microbiological Success Visit 4	19 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

Population: All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Cmax - The peak Nemonoxacin concentration at Day 1-2 of treatment

C-22.5hours - 22.5-h drug concentration of Nemonoxacin

Outcome measures

Measure	Nemonoxacin n=15 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Nemnoxacin Concentration Changes Cmax	8163.84 ng/ml Standard Deviation 2936.57	—
Nemnoxacin Concentration Changes C-22.5hours	359.63 ng/ml Standard Deviation 255.88	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

Population: All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

AUC (0-22.5) - Area under the concentration-time curve from 0 to 22.5 hours of Nemonoxacin

AUC(0-∞) - Areas under the concentration-time curve from 0 h to infinity of Nemonoxacin

Outcome measures

Measure	Nemonoxacin n=16 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Area Under the Concentration-time Curve (AUC) of Nemonoxacin AUC (0-22.5)	34372.69 hours*ng/ml Standard Deviation 12881.56	—
Area Under the Concentration-time Curve (AUC) of Nemonoxacin AUC(0-∞)	38560.90 hours*ng/ml Standard Deviation 15872.29	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

Population: All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Total systemic clearance of Nemonoxacin

Outcome measures

Measure	Nemonoxacin n=16 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Сlearance (CL) of Nemonoxacin	247.32 ml/min Standard Deviation 86.92	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

Population: All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Volume of distribution at steady state of Nemonoxacin

Outcome measures

Measure	Nemonoxacin n=16 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Volume of Distribution at Steady State (Vss) of Nemonoxacin	123.76 liters Standard Deviation 39.15	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

Population: All patients who were included in Pharmacokinetic study and who had at least 1 measured concentration value.

Terminal elimination half-life of Nemonoxacin

Outcome measures

Measure	Nemonoxacin n=16 Participants Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Terminal Elimination Half-life (T1/2) of Nemonoxacin	7.04 hours Standard Deviation 1.98	—

Adverse Events

Nemonoxacin

Serious events: 0 serious events

Other events: 86 other events

Deaths: 0 deaths

Tavanic®

Serious events: 2 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nemonoxacin n=171 participants at risk Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=169 participants at risk Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Infections and infestations Pneumonia	0.00% 0/171 • Up to 23 Days after the last dose of treatment	0.59% 1/169 • Number of events 1 • Up to 23 Days after the last dose of treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/171 • Up to 23 Days after the last dose of treatment	0.59% 1/169 • Number of events 1 • Up to 23 Days after the last dose of treatment

Other adverse events

Measure	Nemonoxacin n=171 participants at risk Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules). Nemonoxacin: Solution for infusion, 500 mg (250 ml) Nemonoxacin: Capsules, 250 mg Placebo (100 ml): 0.9% NaCl (100 ml), solution for infusion	Tavanic® n=169 participants at risk Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet). Tavanic: Solution for infusion, 500 mg (100 ml) Tavanic: Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg Placebo (250 ml): 0.9% NaCl (250 ml), solution for infusion
Investigations Alanine aminotransferase increased	8.2% 14/171 • Number of events 15 • Up to 23 Days after the last dose of treatment	5.3% 9/169 • Number of events 9 • Up to 23 Days after the last dose of treatment
Investigations Platelet count increased	5.8% 10/171 • Number of events 10 • Up to 23 Days after the last dose of treatment	4.1% 7/169 • Number of events 7 • Up to 23 Days after the last dose of treatment
Investigations Gamma-glutamyltransferase increased	5.8% 10/171 • Number of events 10 • Up to 23 Days after the last dose of treatment	3.0% 5/169 • Number of events 5 • Up to 23 Days after the last dose of treatment
Investigations Aspartate aminotransferase increased	3.5% 6/171 • Number of events 6 • Up to 23 Days after the last dose of treatment	3.6% 6/169 • Number of events 6 • Up to 23 Days after the last dose of treatment
Investigations Blood creatinine increased	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	2.4% 4/169 • Number of events 4 • Up to 23 Days after the last dose of treatment
Investigations Red blood cell sedimentation rate increased	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	2.4% 4/169 • Number of events 4 • Up to 23 Days after the last dose of treatment
Investigations Blood glucose increased	1.8% 3/171 • Number of events 3 • Up to 23 Days after the last dose of treatment	0.59% 1/169 • Number of events 1 • Up to 23 Days after the last dose of treatment
Investigations Eosinophil count increased	0.58% 1/171 • Number of events 1 • Up to 23 Days after the last dose of treatment	1.8% 3/169 • Number of events 3 • Up to 23 Days after the last dose of treatment
Investigations Blood alkaline phosphatase increased	0.58% 1/171 • Number of events 1 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Investigations Blood potassium increased	0.58% 1/171 • Number of events 1 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Investigations Transaminases increased	1.8% 3/171 • Number of events 3 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Investigations Blood creatine phosphokinase increased	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Investigations Electrocardiogram QT prolonged	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Gastrointestinal disorders Diarrhoea	5.8% 10/171 • Number of events 10 • Up to 23 Days after the last dose of treatment	3.6% 6/169 • Number of events 6 • Up to 23 Days after the last dose of treatment
General disorders Injection site pain	2.3% 4/171 • Number of events 9 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
General disorders Injection site erythema	1.8% 3/171 • Number of events 4 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
General disorders Injection site reaction	1.8% 3/171 • Number of events 3 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
General disorders Injection site hypoaesthesia	1.2% 2/171 • Number of events 4 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Infections and infestations HIV infection	0.58% 1/171 • Number of events 1 • Up to 23 Days after the last dose of treatment	1.8% 3/169 • Number of events 3 • Up to 23 Days after the last dose of treatment
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/171 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Respiratory, thoracic and mediastinal disorders Pleurisy	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Respiratory, thoracic and mediastinal disorders Throat irritation	1.2% 2/171 • Number of events 4 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Infections and infestations Pneumonia	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	0.59% 1/169 • Number of events 1 • Up to 23 Days after the last dose of treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/171 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Blood and lymphatic system disorders Eosinophilia	3.5% 6/171 • Number of events 6 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment
Skin and subcutaneous tissue disorders Hyperhidrosis	0.58% 1/171 • Number of events 1 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Cardiac disorders Tachycardia	0.58% 1/171 • Number of events 1 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Nervous system disorders Headache	1.8% 3/171 • Number of events 3 • Up to 23 Days after the last dose of treatment	1.8% 3/169 • Number of events 3 • Up to 23 Days after the last dose of treatment
Musculoskeletal and connective tissue disorders Back pain	1.2% 2/171 • Number of events 2 • Up to 23 Days after the last dose of treatment	0.59% 1/169 • Number of events 1 • Up to 23 Days after the last dose of treatment
Renal and urinary disorders Leukocyturia	0.00% 0/171 • Up to 23 Days after the last dose of treatment	1.2% 2/169 • Number of events 2 • Up to 23 Days after the last dose of treatment
Vascular disorders Hypertension	1.2% 2/171 • Number of events 3 • Up to 23 Days after the last dose of treatment	0.00% 0/169 • Up to 23 Days after the last dose of treatment

Additional Information

Aleksandr Chernavin, Regional Medical Director

R-Pharm

Phone: 0074959567937

Email: chernavin@rpharm.ru

Results disclosure agreements

• Principal investigator is a sponsor employee Any study related information could be made public available only after Sponsors written permission.
• Publication restrictions are in place

Restriction type: OTHER